Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent prior to participation in the study.
Age ≥ 18 years.
Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin).
Patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.
Disqualifiers
History of infusion reactions to bevacizumab.
Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
Pregnancy or breast feeding.
Trial design
Design model
Single group
Treatments tested in this trial
injection with 15 mg bevacizumab-800CW before bronchoscopy
DrugPatients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.
injection with 25 mg bevacizumab-800CW before bronchoscopy
DrugPatients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mgExperimental treatment 1 intervention
Group B: Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fluorescent signal of malignant lesion versus non-tumorous tissue.
Comparison of the in vivo fluorescent signal of malignant lesion (pulmonary nodule or lymph node metastasis) versus non-tumorous tissue: The fluorescent signal will be assessed qualitatively (categorical data) and quantitatively (pulmonary nodule: by multi-diameter single fiber reflectance spectroscopy/single-fiber fluorescence spectroscopy (MDSFR/SFF), lymph node metastases: by ultrasound guided needle biopsy single-fiber fluorescence (USNB/SFF)).
Time frame
Assessed directly during the bronchoscopy procedureSecondary outcomes
1
FLuorescence signal analyses
Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results.
Time frame
Up to 1 year2
Optimal dose of bevacizumab-800CW
Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.
Time frame
Up to 1 year3
Safety of bevacizumab-800CW injection and fluorescence molecular imaging
Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescence molecular imaging through summaries of adverse events, including data on the additional time (in minutes) needed for in vivo qualitative and quantitative assessment of the fluorescent signal. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0.
Time frame
Up to 24 hours after the fluorescence molecular bronchoscopySponsors and contacts
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Source ClinicalTrials.gov
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